Objectives
To descriptively analyse public assessment reports (PAR) published by the MHRA through their early access to medicines scheme (EAMS) to establish any trends in product characteristics granted a positive scientific opinion (SO), the impact of an SO on subsequent technology assessment (TA) by the National Institute for Health and Care Excellence (NICE), and the impact of the COVID-19 pandemic on the EAMS process.
Methods
All available PARs and NICE TA documents were obtained from their respective websites, and data relating to drug, indication, justifications for positive SO, and NICE recommendation details extracted.
Results
Of the 41 available PARs published between July 2015 and June 2021, oncology and genetic disorders were the most assessed indications with 24 (58.5%), and 9 (22%) related PARs respectively. The most frequent drug class were monoclonal antibodies, featuring in n=19 (46%) PARs. Of those granted an SO, n=28 underwent a NICE TA resulting in n=26 approvals, of which n=4 were recommended for use only within the cancer drugs fund. Of the recommended therapies, 20 (77%) had a commercial agreement such as a simple discount patient access scheme, in place. During the COVID-19 pandemic (April 2020-April 2021), 11 drugs were granted a positive SO versus 5 drugs in the previous 12 months. Monoclonal antibodies were the most common drug class in both time periods, with 3 (27%) and 2 (40%) granted an SO between April 2019-2020, and April 2020-2021 respectively.
Conclusions
High rates of NICE TA approval (>90%) were observed in products granted an positive SO through EAMS however, most were subject to a commercial agreement, suggesting that engaging with the EAMS scheme doesn’t lead to preferential pricing. The COVID-19 pandemic appears to have had no impact on the EAMS scheme, with an increase noted in the number of positive SOs granted during the pandemic versus the previous year.